scholarly journals Comparative effectiveness and safety of homologous two-dose ChAdOx1 versus heterologous vaccination with ChAdOx1 and BNT162b2: a cohort analysis

2021 ◽  
Author(s):  
Daniel Prieto-Alhambra ◽  
Eduardo Hermosilla ◽  
Ermengol Coma ◽  
Junqing Xie ◽  
Shuo Feng ◽  
...  
Keyword(s):  
Comparative Effectiveness ◽  
Linked Data ◽  
Cohort Analysis ◽  
Vaccination Schedule ◽  
Negative Control ◽  
Number Needed To Treat ◽  
Phase 2 ◽  
Randomised Trials ◽  
Exact Matching ◽  
Previous Phase

Abstract Small trials have suggested that heterologous vaccination with first-dose ChAdOx1 and second-dose BNT162b2 may generate a better immune response than homologous vaccination with two doses of ChAdOx1. We used linked data from Catalonia (Spain), where those aged <60 who received a first dose of ChAdOx1 could choose between ChAdOx1 and BNT162b2 for their second dose. Comparable cohorts were obtained after exact-matching 14,325/17,849 (80.3%) people receiving heterologous vaccination to 14,325/149,386 (9.6%) receiving homologous vaccination by age, sex, region, and date of second dose. Of these, 238 (1.7%) in the heterologous and 389 (2.7%) in the homologous groups developed COVID-19 between 1st June 2021 and 11th October 2021. The resulting hazard ratio (95% confidence interval) was 0.61 [ 0.52-0.71 ], favouring heterologous vaccination, with a Number Needed to Treat of 94.9 [ 71.8 - 139.8 ]. The two groups had similar testing rates and safety outcomes. Sensitivity and negative control outcome analyses confirmed these findings. In conclusion, we demonstrate that a heterologous vaccination schedule with ChAdOx1 followed by BNT162b2 was more efficacious than and similarly safe to homologous vaccination with two doses of ChAdOx1. Most of the infections in our study occurred when Delta was the predominant SARS-CoV-2 variant in Spain. These data agree with previous phase 2 randomised trials.

Meta-analysis and machine learning-augmented mixed effects cohort analysis of improved diets among 5,847 medical trainees, providers, and patients

2021 ◽  
pp. 1-27
Author(s):  
Dominique J. Monlezun ◽  
Christopher Carr ◽  
Tianhua Niu ◽  
Francesco Nordio ◽  
Nicole DeValle ◽  
...  
Keyword(s):  
Machine Learning ◽  
Cohort Study ◽  
Nutrition Education ◽  
Meta Analysis ◽  
Cohort Analysis ◽  
Cost Effective ◽  
Number Needed To Treat ◽  
Nutrition Counseling ◽  
Medical Trainees ◽  
Hands On

Abstract Objective: We sought to produce the first meta-analysis (of medical trainee competency improvement in nutrition counseling) informing the first cohort study of patient diet improvement through medical trainees and providers counseling patients on nutrition. Design: (Part A) A systematic review and meta-analysis informing (Part B) the intervention analyzed in the world’s largest prospective multi-center cohort study on hands-on cooking and nutrition education for medical trainees, providers, and patients. Settings: (A) Medical educational institutions. (B) Teaching kitchens. Participants: (A) Medical trainees. (B) Trainees, providers, and patients. Results: (A) Of the 212 citations identified (N=1,698 trainees), 11 studies met inclusion criteria. The overall effect size was 9.80 (95%CI 7.15-12.456.87-13.85; p<0.001), comparable to the machine learning (ML)-augmented results. The number needed to treat for the top performing high quality study was 12. (B) The hands-on cooking and nutrition education curriculum from the top performing study was applied for medical trainees and providers who subsequently taught patients in the same curriculum (N=5,847). The intervention compared to standard medical care and education alone significantly increased the odds of superior diets (high/medium versus low Mediterranean diet adherence) for residents/fellows most (OR 10.79, 95%CI 4.94-23.58; p<0.001) followed by students (OR 9.62, 95%CI 5.92-15.63; p<0.001), providers (OR 5.19, 95%CI 3.23-8.32, p<0.001), and patients (OR 2.48, 95%CI 1.38-4.45; p=0.002), results consistent with those from ML. Conclusions: This study suggests that medical trainees and providers can improve patients’ diets with nutrition counseling in a manner that is clinically and cost effective and may simultaneously advance societal equity.

512 Late-Breaking: A Postbiotic from Lactobacillus Acidophilus Fermentation (LAF) Accelerates Progression of Compositional and Functional Gut Microbiome Clusters and Promotes Body Weight in Nursery Pigs

2021 ◽  
Vol 99 (Supplement_3) ◽  
pp. 209-210
Author(s):  
Ehsan Khafipour ◽  
Anirikh Chakrabarti ◽  
Maria Sardi ◽  
Briana Kozlowicz ◽  
Derek B Petry ◽  
...  
Keyword(s):  
Gut Microbiome ◽  
Lactobacillus Acidophilus ◽  
Phase 1 ◽  
Positive Control ◽  
Negative Control ◽  
Phase 2 ◽  
Shotgun Metagenomics ◽  
Nursery Pigs ◽  
Long Read ◽  
Bacteroidetes Phylum

Abstract This study investigated the effects of a postbiotic from Lactobacillus acidophilus fermentation (LAF) on pig gut microbiome during nursery. Piglets (n = 32) at weaning (day 21 ± 2) were randomized based on BW (7.4 ± 1.7 kg) and received basal diets that met NRC nutrient requirements for phase 1 (d 0–14) and phase 2 (d 14–32) post-wean. Treatments included i) NC, negative control; ii) PC, antibiotic positive control, iii) LAFa (Dia-V™ Nursery, Diamond V, IA) supplemented at 1000 ppm in phase 1 and 1500 ppm in phase 2, and iv) LAFb (Dia-V™ Nursery) supplemented at 2000 and 1000 ppm during phase 1 and 2, respectively. Fecal samples were collected on d 0, 7, 14, and 32 post-wean and subjected to DNA extraction and long read Nanopore shotgun metagenomics to assess composition, function and progression of gut microbiome and their correlations with BW. On d7, PC and LAF supplemented pigs numerically were closer to microbiome of d 14 and 32 compared to NC pigs. From d 0 to 32, pigs progressed through five compositional clusters (P &lt; 0.05). By d 32, more pigs from PC and LAF groups were exhibiting a compositional cluster that was characterized by dominance of members of Bacteroidetes phylum including several Prevotella species. From d 0 to d 32, four microbiome functional clusters were observed (P &lt; 0.05) with varying abundances of carbohydrate-active-enzymes (CAZy). Pigs in LAF groups compared to other treatments exhibited clusters with greater abundances of CAZy that was correlated with greater BW on d 32 (P = 0.004). The 2000 ppm supplementation of LAF in phase 1 and 1500 ppm in phase 2 numerically increased all measured of diversity compared to 1000 ppm. Overall, while PC and LAF groups promoted more similar microbiome compositional clusters compared to NC, LAF pigs exhibited superior functional clusters.

Laparoscopic Cholecystectomy is Safe in Emergency General Surgery Patients with Cirrhosis

2019 ◽  
Vol 85 (10) ◽  
pp. 1146-1149
Author(s):  
Kyle Okamuro ◽  
Brian Cui ◽  
Ashkan Moazzez ◽  
Hayoung Park ◽  
Brant Putnam ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
General Surgery ◽  
Intraoperative Complications ◽  
Open Cholecystectomy ◽  
Cohort Analysis ◽  
Meld Score ◽  
Adverse Outcomes ◽  
Exact Matching ◽  
Emergency General Surgery ◽  
End Stage

Cirrhosis is associated with adverse outcomes after emergency general surgery (EGS). The objective of this study was to determine the safety of laparoscopic cholecystectomy (LC) in EGS patients with cirrhosis. We performed a two-year retrospective cohort analysis of adult patients who underwent LC for symptomatic gallstones. The primary outcome was the incidence of intraoperative complications. Of 796 patients, 59 (7.4%) were cirrhotic, with a median model for end-stage liver disease (MELD) score of 15 (IQR, 7). On unadjusted analysis, patients with cirrhosis were older, more likely to be male (both P < 0.01), diabetic ( P < 0.001), had a higher incidence of preadmission antithrombotic therapy use ( P < 0.02), and experienced a longer time to surgery (3.2 vs 1.8 days, P < 0.001). Coarsened exact matching revealed no difference in intra- or postoperative complications between groups ( P = 0.67). Operative duration was longer in patients with cirrhosis (162 vs 114 minutes, P = 0.001), who also had a nonsignificant increase in the rate of conversion to an open cholecystectomy (14% vs 4%, P = 0.07). The results of this study indicate that LC may be safely performed in EGS patients with cirrhosis.

scholarly journals Pioglitazone and cause-specific risk of mortality in patients with type 2 diabetes: extended analysis from a European multidatabase cohort study

2018 ◽  
Vol 6 (1) ◽  
pp. e000481 ◽  
Author(s):  
Helen Strongman ◽  
Solomon Christopher ◽  
Maila Majak ◽  
Rachael Williams ◽  
Shahram Bahmanyar ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Propensity Score ◽  
Cardiovascular Mortality ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Exposed Group ◽  
Mortality Data ◽  
Exact Matching

ObjectivesDescribe and compare the risk of cardiovascular and non-cardiovascular mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression.Research design and methodsThis exploratory linked database cohort analysis used pooled health and mortality data from three European countries: Finland, Sweden and the UK. Propensity score together with exact matching was used to match 31 133 patients with type 2 diabetes first prescribed pioglitazone from 2000 to 2011, to 31 133 patients never prescribed pioglitazone. Exact matching variables were treatment stage, history of diabetes, diabetes complications and cardiovascular disease, and year of cohort entry. Mean follow-up time was 2.60 (SD 2.00) and 2.69 (SD 2.31) years in the pioglitazone and non-pioglitazone-exposed groups, respectively. Crude cause-specific mortality rates were ascertained. Association with pioglitazone use was estimated using Cox proportional hazards models adjusted a priori for country, age, sex, the propensity score quintile and time-dependent variables representing use of antidiabetic drugs. Stepwise testing identified no additional confounders to include in adjusted models.ResultsThe crude mortality rate was lower in the pioglitazone-exposed group than the non-exposed group for both cardiovascular and non-cardiovascular mortality. Adjusted HRs comparing pioglitazone to alternative antidiabetic exposure were 0.58 (95% CI 0.52 to 0.63) and 0.63 (95% CI 0.58 to 0.68) for cardiovascular and non-cardiovascular mortality, respectively. A protective effect associated with pioglitazone was also found for all specific cardiovascular causes.ConclusionsThis analysis suggests that pioglitazone is associated with a decrease in both cardiovascular and non-cardiovascular mortality. Results should be interpreted with caution due to the potential for residual confounding in this exploratory analysis. Further studies, specifically designed to test the association between pioglitazone use and patient-focused outcomes, are suggested.Study registration numberEuropean Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP; EUPAS3626).

scholarly journals 670. VRE Clearance in Patients with Recurrent Clostridium difficile Infection Following Treatment with Microbiota-Based Drug RBX2660

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S306-S307
Author(s):  
Heidi Hau ◽  
Sarah Mische ◽  
Sarah Klein ◽  
Ken Blount
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Cohort Analysis ◽  
Intestinal Microbiome ◽  
Phase 2 ◽  
Open Label ◽  
Recurrent Clostridium Difficile Infection ◽  
Gram Staining ◽  
Increased Risk ◽  
Stool Samples

Abstract Background Vancomycin-resistant Enterococcus (VRE) infection is frequently associated with immunocompromised and critically ill patients. VRE carriers are at increased risk for infection due to VRE colonization and they pose a risk as a transmission source. VRE infection and Clostridium difficile infection (CDI) share common risk factors, including disruption of the intestinal microbiome. Thus, therapeutic approaches that decolonize VRE would be valuable. Herein, we report on stool VRE clearance in a cohort analysis from a Phase 2 open-label study of RBX2660, standardized microbiota-based drug, for recurrent CDI. Methods This prospective, multicenter, open-label Phase 2 study enrolled subjects with recurrent CDI. Participants received up to 2 doses of RBX2660 delivered via enema with doses 7 days apart. Patients were requested to voluntarily submit stool samples at baseline and at 7, 30 and 60 days, 6, 12, and 24 months after the last administration of RBX2660. Stool samples were tested for VRE using bile esculin azide agar with 6 µg/mL vancomycin and gram staining. Vancomycin resistance was confirmed via blood agar and etest. Results Stool samples were available for 143 patients. Twenty-one patients were VRE-positive at the first test (baseline or 7 day). Of the 19 VRE-positive patients that provided additional samples at later timepoints, 18 (94.7%) converted to negative as of the last available follow-up (30 or 60 days and 6, 12, or 24 months). The remaining patient remained positive at all follow-ups. Conclusion This cohort analysis of VRE-positive patients within an rCDI population provides additional support that microbiota-based formulations, such as RBX2660, may have additional benefit beyond reducing the recurrence of CDI. Additional study is needed to confirm the role of microbiome restoration on VRE clearance. Disclosures All authors: No reported disclosures

scholarly journals Pralatrexate: Phase 1/2 Study in Japanese Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4157-4157
Author(s):  
Yoshinobu Maeda ◽  
Kensei Tobinai ◽  
Hirokazu Nagai ◽  
Takahiko Nakane ◽  
Tatsu Shimoyama ◽  
...  
Keyword(s):  
T Cell ◽  
Research Funding ◽  
Cell Lymphoma ◽  
Phase 1 ◽  
T Cell Lymphoma ◽  
Intermediate Risk ◽  
Phase 2 ◽  
Western Countries ◽  
Phase 2 Study ◽  
Previous Phase

Abstract Introduction:Pralatrexate (PDX) is a dihydrofolate reductase inhibitor with high affinity for reduced folate carrier 1 and folylpolyglutamate synthetase, resulting in extensive internalization and accumulation in tumor cells. In the previous phase 2 study for relapsed or refractory (R/R) PTCL in western countries, the overall response rate (ORR) was 29% (32 of 109 evaluable patients [pts]), as assessed by an independent central review (O'Connor et al. JCO 2011). We conducted this phase 1/2 study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PDX in Japanese pts with R/R PTCL. Methods: Eligibility criteria included age ≥20, histologically confirmed PTCL according to the 2008 WHO classification, disease progression after ≥1 prior systemic therapy, ≥1 measurable disease and Eastern Cooperative Oncology Group performance status ≤2. PDX was administered intravenously weekly for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid. There were 2 cohorts in phase 1: Cohort 1 was at 30 mg/m2 of the US-approved dose and Cohort 2 would start at 20 mg/m2 if 30 mg/m2 was not tolerated. The primary endpoint was ORR in phase 2 and secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS). Response was evaluated by the independent central imaging review using the International Workshop Criteria (Cheson et al. JCO 1999). Cryotherapy and professional oral care (e.g. dental cleaning and oral hygiene instruction) by dentists before and during PDX treatment were recommended to reduce the severity of mucositis. An educational handbook was offered to all pts to learn symptoms, prevention and self-care of oral mucositis. Results:A total of 25 pts received ≥1 dose of PDX and were included in the safety analysis (median age 71 years; 68% male; median of 3 prior therapies; 32% refractory to the most recent therapy; 16% low risk, 48% low-intermediate risk, 24% high-intermediate risk and 12% high risk by International Prognostic Index). Of these, 3 pts were enrolled in phase 1 and 22 pts in phase 2. Two pts in phase 2 were excluded from the efficacy analysis due to lack of a confirmed diagnosis of PTCL by the central pathology review. In phase 1, no dose-limiting toxicity was observed in 3 pts for Cohort 1. In phase 2, using 30 mg/m2 as the recommended dose, the ORR was 45% (9 of 20 evaluable pts in phase 2; 90% CI, 26% to 65%) with 2 complete responses and 7 partial responses achieved in Cycle 1. At the time of data cut-off, median DoR of 9 responders was not reached (range, 1 to 358 days) and 4 responders were still on PDX treatment. The median PFS of all 20 evaluable pts was 150 days (95% CI, 43 to 183). Among 23 evaluable pts for efficacy in phase 1/2, 5 pts had died and median OS was not reached (range, 41 to 570 days) after a median follow-up of 183 days for censored cases. In contrast to the results from the previous phase 2 study in western countries showing the ORR of 8% (1 of 13) in pts with angioimmunoblastic T-cell lymphoma (AITL), the ORR in AITL pts was 44% (4 of 9), which was similar to the ORR in pts with PTCL not otherwise specified (50%; 6 of 12) or pts with anaplastic lymphoma kinase-negative anaplastic large cell lymphoma (50%; 1 of 2) in this study. The plasma PDX concentration peaked immediately after intravenous injection over 3 to 5 minutes and the elimination half-life was about 10 to 20 minutes. The most common grade (G) 3 or 4 adverse events were lymphopenia (52%; 13 pts), thrombocytopenia (40%; 10 pts), leukopenia (28%; 7 pts), neutropenia (24%; 6 pts), anemia (20%; 5 pts). Mucositis was observed in 21 pts (84%) including G1 (20%; 5 pts), G2 (44%; 11 pts) and G3 (20%; 5 pts). G4 mucositis did not occur in any pts. Median duration of G2 mucositis was 8 days (range, 3 to 15) and that of G3 was 12 days (range, 8 to 17). According to the criteria for dose modification, the dose of PDX was reduced to 20 mg/m2 due to mucositis in 6 pts. One pt discontinued the treatment due to G2 mucositis recurrence after dose reduction. All 25 treated pts received ≥1 time cryotherapy at PDX administration and 20 of them continued it throughout the study. Thirteen pts received ≥1 time dental scaling or dental cleaning. Conclusion: PDX at 30 mg/m2 weekly for 6 of 7 weeks was effective and well-tolerated in Japanese pts with R/R PTCL. Early oral or dental care potentially ameliorates mucositis and it may be useful for continuing PDX treatment more safely. This study was sponsored by Mundipharma KK. Disclosures Maeda: Mundipharma KK: Research Funding. Tobinai:Ono Pharmaceutical: Research Funding; Takeda: Honoraria, Research Funding; HUYA Bioscience: Honoraria; Daiichi Sankyo Co., Ltd.: Consultancy; Zenyaku Kogyo: Honoraria; SERVIER: Research Funding; GlaxoSmithKline: Research Funding; Kyowa Hakko Kirin: Research Funding; Janssen Pharmaceuticals: Honoraria, Research Funding; Chugai Pharma: Research Funding; Abbvie: Research Funding; Celgene: Research Funding; Eisai: Honoraria, Research Funding; Mundipharma KK: Honoraria, Research Funding. Nagai:Mundipharma KK: Research Funding; Takeda: Honoraria, Research Funding; Janssen: Research Funding. Nakane:Mundipharma KK: Research Funding. Shimoyama:Mundipharma KK: Research Funding. Nakazato:Mundipharma KK: Research Funding. Sakai:Mundipharma KK: Research Funding. Ishikawa:Mundipharma KK: Research Funding. Izutsu:Eisai: Honoraria; Chugai Pharmaceutical: Honoraria, Research Funding; Kyowa Hakko Kirin: Honoraria; Takeda Pharmaceutical: Honoraria; Janssen Pharmaceutical K.K.: Honoraria; Celgene: Research Funding; Gilead: Research Funding; Abbvie: Research Funding; Mundipharma KK: Research Funding. Ueda:Kyowa Hakko Kirin: Research Funding; Mundipharma KK: Consultancy.

scholarly journals Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine: a randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study).

2021 ◽  
Author(s):  
Francisco Hernandez-Bernal ◽  
Maria del Carmen Ricardo-Cobas ◽  
Yenima Martin-Bauta ◽  
Zadis Navarro-Rodriguez ◽  
Marjoris Pinera-Martinez ◽  
...  
Keyword(s):  
Placebo Group ◽  
Neutralizing Antibodies ◽  
Phase 1 ◽  
Vaccination Schedule ◽  
Phase 2 ◽  
Igg Antibodies ◽  
Protein Vaccine ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Third

Aim: To evaluate the safety and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine (Abdala), administered intramuscularly in different strengths and vaccination schedules. Method: A phase 1-2, randomized, double-blind, placebo-controlled trial was done. Subjects were randomly distributed in 3 groups: placebo, 25 and 50 μg RBD. The product was applied intramuscularly, 0.5 mL in the deltoid region. During the first phase, two immunization schedules were studied: short (0-14-28 days) and long (0-28-56 days). In phase 2, only the short scheme was evaluated. The main endpoints were: safety and proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2. Blood samples were collected in several points according to the corresponding vaccination schedule to determine the level of RBD-specific IgG antibodies (seroconversion rates and geometric mean of the titers), the percentage of inhibition of RBD-ACE-2 binding and levels of neutralizing antibodies. Results: The product was well tolerated. Severe adverse events were not reported. Adverse reactions were minimal, mostly mild and local (from the injection site), resolved in the first 24-48 hours without medication. In phase 1, at day 56 (28 days after the third dose of the short vaccination schedule, 0-14-28 days) seroconversion of anti-RBD IgG was seen in 95.2 % of the participants (20/21) for the 50 μg group and 81 % of the participants (17/21) for the 25 μg group, and none in the placebo group (0/22); whereas neutralizing antibodies to SARS-CoV-2 were seen in 80 % of the participants (8/10) for the 50 μg group and 94.7% of the participants (18/19) for the 25 μg group. For the long schedule, at day 70 (14 days after the third dose) seroconversion of anti-RBD IgG was seen in 100% of the participants (21/21) for the 50 μg group and 94.7% of the participants (18/19) for the 25 μg group, and none in the placebo group (0/22); whereas neutralizing antibodies to SARS-CoV-2 were seen in 95 % of the participants (19/20) for the 50 μg group and 93.8% of the participants (15/16) for the 25 μg group In phase 2, at day 56 seroconversion of anti-RBD IgG was seen in 89.2% of the participants (214/240) for the 50 μg group, 77.7% of the participants (185/238) for the 25 μg group, and 4.6% in the placebo group (11/239); whereas neutralizing antibodies to SARS-CoV-2 were seen in 97.3% of the participants (146/150) for the 50 μg group and 95.1% of the participants (58/61) for the 25 μg group. Conclusion: Abdala vaccine against SARS-CoV-2 was safe, well tolerated and induced humoral immune responses against SARS-CoV-2 among adults from 19 to 80 years of age.

Abstract 16890: Coronary Artery Calcium for Personalizing Antihypertensive Therapy: A Pooled Cohort Analysis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Gargya Malla ◽  
Vibhu Parcha ◽  
Rajat Kalra ◽  
Ambarish Pandey ◽  
Nasir Khurram ◽  
...  
Keyword(s):  
Coronary Artery ◽  
High Risk ◽  
Coronary Artery Calcium ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Low Risk ◽  
Number Needed To Treat ◽  
Atherosclerotic Cardiovascular Disease ◽  
Stage 1

Background: The 2017 American College of Cardiology/American Heart Association high blood pressure (BP) guidelines recommend risk assessment of atherosclerotic cardiovascular disease (CVD) to inform hypertension (HTN) treatment in adults with elevated BP or low-risk stage 1 HTN. Use of coronary artery calcium (CAC) score, an excellent imaging risk-prediction tool, to guide HTN therapy has not been well studied. Methods: Participants free of CVD were pooled from three population cohort studies; 1) Multiethnic Study of Atherosclerosis, 2) Coronary Artery Risk Development in Young Adults and 3) Jackson Heart Study. Risk for incident CVD events (heart failure, stroke or cardiovascular mortality) by the CAC status and the BP treatment group was assessed. Multivariable Cox proportional hazards models were used to estimate the hazard ratios. The 10-year number needed to treat to prevent a single CVD event was also estimated. Results: This study included 11,499 participants (mean age 56 years; 55.2% women; 42.1% blacks). CAC score was non-zero in 38.2% of the participants. Over a median follow-up of 8.5 years, 910 incident CVD events occurred. Compared to those with zero CAC, participants with non-zero CAC score had a higher CVD incidence rate (per 1000 person-years) at all BP levels (elevated BP/low-risk stage 1 HTN: 14.5 vs 2.7; high-risk stage 1 or stage 2 HTN: 27.1 vs 8.8). Multivariable adjusted hazards of adverse CVD events displayed similar patterns ( Figure ). Among those with zero CAC, the 10-year number needed to treat to prevent 1 CVD event was 154 for those with elevated BP/low-risk stage 1 HTN and 47 for those with high-risk stage 1 or stage 2 HTN. Among those with non-zero CAC score, the number needed to treat was lower, 33 and 18 respectively. Conclusions: Utilization of CAC score may be an effective precision medicine approach to personalize HTN therapy in elevated BP or low-risk stage 1 HTN when treatment is not recommended by the current guidelines.

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